EVALUATION OF CHOLECALCIFEROL (VitD3) MAINTENANCE SUPPLEMENTATION IN PATIENTS WITH MULTIPLE MYELOMA (MM) UNDERGOING TRANSPLANTATION AND IN COMBINATION WITH LENALIDOMIDE MAINTENANCE
Amany Keruakous, MD, MS.
Summary
The goal of this clinical trial is to evaluate post-transplant immune reconstitution and lymphocyte recovery as well as the 3-year progression-free survival of patients with multiple myeloma in two treatment arms. One arm will receive Maintenance Vitamin D and the other arm will receive no maintenance Vitamin D prior to ASCT. Post ASCT arm 1 will have lenalidomide and maintenance VitD, and arm 2 will receive lenalidomide and no maintenance VitD. This clinical trial will also evaluate the overall response rate and survival for both treatment arms.
Description
Management of multiple myeloma (MM) has changed significantly over the past 10 years. The use of three drug induction therapy followed by autologous stem cell transplantation (ASCT) has become standard of care for transplant eligible patients with MM since randomized trials showed improved progression-free survival (PFS) and overall survival (OS) with three drugs, albeit in the non-transplant setting. Evidence suggests Vitamin D deficiency is correlated with poorer outcomes in this population; however, it is unknown if intensified Vitamin D supplementation improves outcomes. This clinical tri…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients must be ≥ 18 years of age at time of registration to Step 1. 2. Patients must have history and physical exam within 28 days prior to registration. 3. Patients must have Zubrod/ECOG Performance Status ≤ 2. 4. Patients must have had a confirmed diagnosis of symptomatic MM (See Section 4.1) with measurable disease at the time of myeloma diagnosis that required systemic induction therapy prior to ASCT. Measurable disease is defined as measurable M protein in the serum (≥ 0.5g/dL) or urine (≥ 200 mg/24h) or serum free light chain assay (defined as ≥ 10 mg/dL \[≥ 100…
Interventions
- DrugLenalidomide
For first three cycles, taken orally once daily for 28 days at 10mg/day dose. After cycle 4, taken orally once daily at 15 mg/day dose
- DrugMaintenance Vitamin D
After replacement of vitamin D deficiency with weekly cholecalcefirol 50,000 units untill levels are \> 30, will start maintenance therapy with Monthly replacement with 50,000 IU
- DrugNo maintenance Vitamin D
After replacement of vitamin D deficiency with weekly cholecalcefirol 50,000 units untill levels are \> 30, stop replacement and continue monitoring levels
Location
- Georgia Cancer Center at Augusta UniversityAugusta, Georgia